Todos Medical has extended its agreement with 3D Medicines Corporation for testing products for Covid-19 coronavirus. As per the newly signed Medical Device Contract Manufacturing Agreement, Todos has received the rights to apply for US Food & Drug Administration (FDA) Emergency Use Authorization (EUA) for 3D Med’s SARS-CoV-19 along with exclusive rights for branding and distribution of 3D Med’s qPCR test kits in the US.
Beroni Group has announced its collaboration with Forsitech and Standard Capital to supply its SARS-CoV-2 total antibody detection kit in Japan. The company first plans to supply around 100,000 test kits to these two Japanese partners. Standard Capital’s ALLEX platform will be used for smooth and quick delivery of the test kits.
Bureau Veritas has announced that the Katubedda laboratory in Sri Lanka has received ISO/IEC 17025 accreditation for ‘new scope related to medical or surgical face masks’. With this accreditation, face mask buyers and suppliers around the world can test medical masks including the entire EU market entry scope in the laboratory.
The FDA has granted new EUA for Covid-19 tests developed by University of California-San Francisco (UCSF) and BioSewoom. UCSF’s Health Clinical Laboratories-UCSF Clinical Labs at China Basin received the EUA for its molecular-based SARS-CoV-2 RNA DETECTR Assay while BioSewoom was granted the EUA molecular-based Real-Q 2019-nCoV Detection Kit.